UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029184
Receipt number R000033366
Scientific Title Feasibility study of internet-based guided self-help cognitive behavioral therapy for workers with subthreshold depression
Date of disclosure of the study information 2017/09/19
Last modified on 2022/09/15 16:13:37

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Basic information

Public title

Feasibility study of internet-based guided self-help cognitive behavioral therapy for workers with subthreshold depression

Acronym

Stress check study

Scientific Title

Feasibility study of internet-based guided self-help cognitive behavioral therapy for workers with subthreshold depression

Scientific Title:Acronym

Stress check study

Region

Japan


Condition

Condition

subthreshold depression

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the safety and efficacy of the internet-based guided self-help cognitive behavioral therapy with subthreshold depression

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II


Assessment

Primary outcomes

The Center for Epidemiological Studies Depression scale (CES-D)

Key secondary outcomes

1. Beck Depression Inventory-II (BDI-II)
2. General Health Questionnaire-12 (GHQ12)
3. QOL (EQ-5D-5L)
4. Sheehan Disability Scale (SDISS)
5. Presenteeism (Stanford Presenteeism Scale (SPS)
6. Cognitive Control Scale
7. Quick Inventory of Depressive Symptomatology (QIDS-J)
8. Session Rating Scale (SRS)
9. Onset of depressive disorders at the 36 weeks follow-up


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Internet-based guided self-help cognitive behavioral therapy

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

66 years-old >

Gender

Male and Female

Key inclusion criteria

1. Workers with high stress-related symptoms and conditions assessed by the Stress Check Test
2. The Center for Epidemiological Studies-Depression (CES-D) > = 16 at the baseline
3. Age 20 years or older, and 65 years or younger at the baseline
4. Subjects who give full consent in the participation of the study

Key exclusion criteria

1. Subjects with current DSM-IV major depressive disorder or during treatment for depression at the baseline
2. Subjects with manic episode or psychotic disorders or during treatment for bipolar disorder or psychotic disorders at the baseline
3. During treatment with antidepressant, mood stabilizer or antipsychotics at the baseline
4. Serious suicidal ideation at the baseline
5. Structured psychotherapy during the intervention
6. Other relevant reason decided by the investigators

Target sample size

15


Research contact person

Name of lead principal investigator

1st name Reiji
Middle name
Last name Yoshimura

Organization

University of Occupational and Environmental Health, Japan

Division name

Department of Psychiatry

Zip code

807-0804

Address

1-1, Iseigaoka, Yahatanishi-ku Kitakyushu-shi, Fukuoka, 807-0804, Japan

TEL

093-691-7253

Email

yoshi621@med.uoeh-u.ac.jp


Public contact

Name of contact person

1st name Kensuke
Middle name
Last name Utsunomiya

Organization

University of Occupational and Environmental Health, Japan

Division name

Department of Psychiatry

Zip code

807-0804

Address

1-1, Iseigaoka, Yahatanishi-ku Kitakyushu-shi, Fukuoka, 807-0804, Japan

TEL

093-691-7253

Homepage URL


Email

k-utsu@med.uoeh-u.ac.jp


Sponsor or person

Institute

University of Occupational and Environmental Health, Japan

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor

Keio University School of Medicine

Name of secondary funder(s)



IRB Contact (For public release)

Organization

University of Occupational and Environmental Health, Japan

Address

1-1, Iseigaoka, Yahatanishi-ku Kitakyushu-shi, Fukuoka, 807-0804, Japan

Tel

093-691-7205

Email

daigakukanri@mbox.pub.uoeh-u.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2017 Year 09 Month 19 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2017 Year 08 Month 25 Day

Date of IRB

2017 Year 09 Month 05 Day

Anticipated trial start date

2017 Year 09 Month 19 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 09 Month 19 Day

Last modified on

2022 Year 09 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033366


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name